BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER

    MDR report key: 7156454 · Received January 2, 2018

    Report

    Report Number
    8031673-2017-00224
    Event Type
    Malfunction
    Date Received
    January 2, 2018
    Date of Event
    December 1, 2017
    Report Date
    May 18, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: ON 04-DEC-2017 A FIELD SERVICE ENGINEER (FSE) CONFIRMED THE REPORTED ISSUE. THE FSE REPLACED THE SYRINGE-L IN ORDER TO RESOLVE THE ISSUE. THE FSE POWERED-UP THE G8 INSTRUMENT WITHOUT ANY ERRORS. THE G8 INSTRUMENT WAS FUNCTIONING WITHIN SPECIFICATIONS AFTER COMPLETING THE REPAIR. THE G8, SERIAL NUMBER (B)(4), WAS INSTALLED THE ACCOUNT ON 25-OCT-2017. A COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FROM 25-OCT-2017 THROUGH (B)(6) 2017. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE G8 OPERATOR'S MANUAL UNDER CHAPTER 6 - TROUBLESHOOTING, INDICATES THAT 706 SYRINGE-L ERROR MESSAGE IS GENERATED WHEN AN OPERATION ERROR OCCURS WITH THE SYRINGE-L. THE OPERATOR IS INSTRUCTED TO INSPECT THE SYRINGE-L. THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE WAS DUE TO A CLOGGED SYRINGE-L.

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR SERIAL NUMBER 15037404, WHICH CONFIRMED THAT THERE WERE NO NONCONFORMANCES, FAILURES, DISCREPANCIES, OR MISSED STEPS DURING THE MANUFACTURING PROCESS THAT COULD BE RELATED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED GETTING 706 SYRINGE-L ERROR MESSAGE WHILE RUNNING PATIENT SAMPLES ON THE G8 INSTRUMENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR HEMOGLOBIN A1C (HBA1C). THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751 TOSOH HLC-723G8 ANALYZER G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1